Li Xiaojing, Jin Su, Guo Shuyang, Yang Dan, Sai Wenbo, Qiu Xiao, Zhao Xin, Wang Lan, Wang Tao, Li Min
Center for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
State Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing 102629, China.
Vaccines (Basel). 2024 Dec 20;12(12):1436. doi: 10.3390/vaccines12121436.
The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions. Despite significant efforts to establish standardized regulatory procedures, challenges remain, particularly in achieving a unified definition and application of platform technology across regions. This paper explores the evolution, applications, and regulatory strategies of platform technology, with a focus on China's experience in this field. China's approach, encompassing risk assessment, and the expedited approval of emergency vaccines, offers valuable insights into global regulatory coordination. By analyzing China's regulatory contributions and international practices, this paper highlights the potential of platform technology to address future pandemics, including "Pathogen X", and underscores the importance of harmonizing global regulatory efforts to strengthen public health preparedness and response.
“平台技术”的概念在埃博拉疫情爆发后开始受到关注，自那时起便成为国际疫苗（针对传染病的预防性疫苗）监管框架的核心要素。在新冠疫情期间，其重要性进一步凸显，平台技术助力疫苗快速研发与获批，优化监管流程，提升全球公共卫生应对能力。作为一种变革性工具，平台技术简化了产品研发过程，减少临床试验数量或豁免某些临床试验，并便于监管申报中的交叉引用。尽管为建立标准化监管程序付出了巨大努力，但挑战依然存在，尤其是在跨地区实现平台技术的统一界定和应用方面。本文探讨了平台技术的演变、应用及监管策略，重点关注中国在该领域的经验。中国的做法，包括风险评估和应急疫苗的快速审批，为全球监管协调提供了宝贵见解。通过分析中国的监管贡献和国际实践，本文强调了平台技术应对未来大流行（包括“X病原体”）的潜力，并突显了协调全球监管努力以加强公共卫生防范和应对的重要性。
